Method and apparatus for transdermal or transmucosal application of testosterone

Abstract

Methods, formulations, and devices for providing transdermal or transmucosal delivery of active agents to subjects in need thereof. The formulations and methods treat symptoms of hormonal disorders including hypogonadism, female sexual desire disorder, female menopausal disorder, and adrenal insufficiency.

Description

[0001]This application claims the benefit of provisional application No. 60 / 685,132 filed May 27, 2005, the entire content of which is expressly incorporated herein by reference thereto.FIELD OF INVENTION[0002]The present invention relates generally to a method, formulation and system for providing transdermal or transmucosal delivery of active agents to a subject. In particular, the invention relates to an improved method and formulation for treating female menopausal symptoms, female sexual desire disorder, and hypoactive sexual desire disorder. The invention also relates to a system for dispensing a precise dosage of a fluid medicament.BACKGROUND OF THE INVENTION[0003]Reduced levels of endogenous steroid hormones in humans often lead to a variety of undesirable clinical symptoms. For example, low testosterone levels in men (hypogonadism) may result in clinical symptoms including impotence, lack of sex drive, muscle weakness, and osteoporosis. Similarly, in women, reduced levels o...

AI Technical Summary

Benefits of technology

The testosterone gel formulation effectively increases serum testosterone levels, alleviating symptoms of menopause and hypoactive sexual desire disorder, with the metered dosage device ensuring accurate and consistent dosing, improving patient compliance and treatment efficacy.

Problems solved by technology

Reduced levels of endogenous steroid hormones in humans often lead to a variety of undesirable clinical symptoms.

For example, low testosterone levels in men (hypogonadism) may result in clinical symptoms including impotence, lack of sex drive, muscle weakness, and osteoporosis.

Moreover, reduced levels of estrogen and / or progesterone in women, such as that caused by menopause, often result in clinical symptoms including hot flashes, night sweats, vaginal atrophy, decreased libido, and osteoporosis.

Currently, there are no testosterone products approved in the U.S. for treatment of HSDD in women.

For example, orally administered testosterone is largely degraded in the liver, and is therefore not a viable option for hormone replacement since it does not allow testosterone to reach systemic circulation.

Further, analogues of testosterone modified to reduce degradation (e.g., methyltestosterone and methandrostenolone) have been associated with abnormalities in liver function, such as elevation of liver enzymes and conjugated bilirubin.

Injected testosterone produces wide peak-to-trough variations in testosterone concentrations that do not mimic the normal fluctuations of testosterone, and makes maintenance of physiological levels in the plasma difficult.

Injections require large needles for intramuscular delivery, which leads to diminished patient compliance due to discomfort.

A transdermal patch or such other adhesive device, however, still presents disadvantages such as user discomfort, skin irritation due to the adhesive required to secure the patch to a pat of the user's body, and also the discomfort due to removal of the patch, during which both the user's skin and hair can be pulled.

Although administration of drugs in a gel form is favorable to users due to its pain-free and discreet administration, it has a drawback of difficulty in dispensing the proper dosage for administration.

This is problematic especially because it requires careful dispensing of the medicament, and precise measuring on the part of the user to ensure administration of the proper dosage.

Oftentimes users over- or under-dose themselves due to carelessness or simply because it is difficult to measure the amount of medicament dispensed from the particular tube.

Accordingly, administering an accurate dosage amount of a gel-type medicament from such containers is difficult, and usually only a ballpark measure can be dispensed.

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